How do you choose your surgical gown?...What are AAMI surgical gown standards? • ANSI/AAMI...

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registered trademarks of Cardinal Health. 1 © Copyright 2016, Cardinal Health. All rights reserved. CARDINAL HEALTH, the Cardinal Health LOGO and ESSENTIAL TO CARE are trademarks or registered trademarks of Cardinal Health. Activity # 3820

How do you choose your surgical gown?A guide to AAMI barrier protection standards

Sandy Albright MSHM BSN RN CNORe A. Name

Sr. Clinical Consultant

June 6, 2017

© 2016 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO and ESSENTIAL TO CARE are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.2

Welcome

Sandy Albright MSHM BSN RN CNOR


Cardinal Health

Hospital Sales and Service


Objectives

Discuss the importance of managing infection risk in the OR

Describe the purpose of AAMI and its gown standards

Outline the four AAMI barrier protection levels

Know the 3 questions you should ask yourself before choosing a gown

Review how clinicians and materials management should collaborate to improve gown purchases

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About Cardinal Health

Recognized leader in healthcare supply chain transformation

• Top ranking for transforming the healthcare value chain to meet new

challenges around costs, revenues and outcomes

Unparalleled understanding of healthcare value chain

• Supplier and leading manufacturer of med/surg products

• Leader in providing supply chain services with 40+ years experience

Industry-leading manufacturer of surgical gowns*

• Simple way to support your reputation of delivering quality care,

while lowering costs at the same time

*2016 GHX data.


Two main purposes of surgical gowns

1. Protect patients from microorganisms carried by surgical

team or patients themselves

2. Protect healthcare providers from contact with infectious

microorganisms harbored by patients


Why focus on the risk of infection?

• New pathogens and drug-resistant organisms

• Clinical emphasis on reducing healthcare-associated infections (HAIs)

• Renewed efforts to improve patient and staff safety

– Support quality outcomes

– Enhance patient and staff satisfaction

– Protect reimbursements (help avoid “never events” and minimize 30-day readmission

penalties)


Consequences of underestimating risk

• Pathogens transmitted through blood, fluids and skin cells can cause

dangerous infections

– Human Immunodeficiency Virus (HIV)

– Hepatitis B and C viruses

• Surgical site infections are the most common infection type*

– $11,000 - $35,000 cost per incident

– $3 billion - $10 billion annual cost industrywide

*The Direct Medical Costs of Healthcare-Associated Infections in U.S. Hospitals and the Benefits of Prevention. Centers for Disease Control,

http://www.cdc.gov/HAI/pdfs/hai/Scott_CostPaper.pdf, Table 4 and Table 5

http://www.cdc.gov/HAI/pdfs/hai/Scott_CostPaper.pdf


What is the AAMI?

• AAMI = Association for the Advancement of Medical Instrumentation

• Nonprofit organization founded in 1967

• Nearly 7,000 members with clinical, manufacturing and regulatory

expertise

• Primary source for medical device standards


What are AAMI surgical gown standards?

• ANSI/AAMI PB70:2012 - A set of surgical gown standards that all

manufacturers must meet

• Adopted by U.S. Food and Drug Administration (FDA) as testing

standard manufacturers must follow

• Outlines testing requirements for four different AAMI levels of barrier

protection


Look for AAMI label

• FDA discourages use of vague words such as “impervious” or

“impermeable”; easily misinterpreted and potentially misleading

– Lacks specificity regarding performance and test methods

– ANSI/AAMI PB70:2012 developed to address these issues and provide clarity

• Rely on AAMI level on gown label


How are barrier protection levels defined?

• Depends primarily on potential exposure to and level of protection from:

– Blood

– Bodily fluids

– Other potentially infectious materials (OPIM)

• Classification of barrier performance based on the “hierarchy of risks”

• Risk levels organized by the type/volume of fluids and duration of exposure


What are four AAMI levels?

• Barrier protection ranked on a scale of 1 – 4

– #1 minimal protection

– #2 low protection

– #3 moderate protection

– #4 high protection

*AAMI levels determined per ANSI/AAMI PB70:2012


AAMI Levels 1 - 2

As Noted in the AAMI Technical Information Report (TIR), No. 11:2005

-Selection and use of protective apparel and surgical drapes in health care facilities

*Suggested guidelines are not a substitute for clinician professional judgment and experience



AAMI Levels 3 - 4

As Noted in the AAMI Technical Information Report (TIR), No. 11:2005

-Selection and use of protective apparel and surgical drapes in health care facilities

*Suggested guidelines are not a substitute for clinician professional judgment and experience



How are surgical gowns tested?

• Range of factors used to establish

barrier effectiveness

• Includes materials’ resistance to

water/blood penetration

• Typically four different areas must

pass within the critical zones

• Two in front, two on the sleeve


3 questions to choose your next gown

1. How much fluid do you expect to be present

during the procedure?

2. How long will this procedure last?

3. What is my role in the procedure?


Collaboration is key

• Clinicians and materials management should work together to improve

gown purchasing—weighing such factors as:

– Risk of surgical site infections

– Cost control: don’t use more protection than needed

– Clinicians’ personal preference and comfort

• Use AAMI standards to determine product mix needed at each facility

(avoid over- and under-protection)

• Streamline product and vendor selection to maximize safety and cost-

effectiveness

© Copyright 2016, Cardinal Health. All rights reserved. CARDINAL HEALTH, the Cardinal Health LOGO and ESSENTIAL TO CARE are trademarks or registered trademarks of Cardinal Health. 18 © Copyright 2016, Cardinal Health. All rights reserved. CARDINAL HEALTH, the Cardinal Health LOGO and ESSENTIAL TO CARE are trademarks or registered trademarks of Cardinal Health. Activity # 382018 © Copyright 2016, Cardinal Health. All rights reserved. CARDINAL HEALTH, the Cardinal Health LOGO and ESSENTIAL TO CARE are trademarks or registered trademarks of Cardinal Health. Activity # 3820

Q&ASandy Albright MSHM BSN RN CNOR


Cardinal Health

Hospital Sales and Service

www.cardinalhealth.com/<URL>

How do you choose your surgical gown?...What are AAMI surgical gown standards? • ANSI/AAMI...

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